A Clinical Trial of Fluvoxamine for Melancholia
NCT04160377, Phase 2, Unknown, Lingjiang Li
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Clinical Trial of Fluvoxamine for Melancholia | ClinicalTrials.gov |
| NCT number | NCT04160377 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 150 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Lingjiang Li | ClinicalTrials.gov |
| Conditions | Depressive Disorder, Endogenous Depression, Melancholia | ClinicalTrials.gov |
| Interventions | Fluvoxamine | ClinicalTrials.gov |
| First posted | 2019-11-13 | ClinicalTrials.gov |
| Last updated | 2022-04-12 | ClinicalTrials.gov |
Registered outcomes 26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Hamilton Depression Rating Scale-17 item (HAMD-17) | Baseline, 2weeks, 1 months, 2 months | Interview-based questionnaire used to measure the severity of depression. Consists of 17 items with a score calculated. Higher scores are associated with more severe depression. | ClinicalTrials.gov |
| Primary | Change in Hamilton Anxiety Rating Scale-14 item (HAMA-14) | Baseline, 1 months, 2 months | Interview-based questionnaire used to measure the severity of anxiety. Consists of 14 items with a score calculated. Higher scores are associated with more severe anxiety. | ClinicalTrials.gov |
| Primary | Change in voxel-based morphometry of grey matter, white matter as assessed by structural magnetic resonancce imaging | Baseline, 2 months | Participants will receive resting-state functional magnetic resonance imaging (MRI). Scans will be performed on a 3.0- T Siemens Magnetom Skyra scanner (Siemens Healthineers, Erlangen, Germany). During scanning, all participants were instructed to remain motionless, and to think of nothing in particular but to not fall asleep. | ClinicalTrials.gov |
| Primary | Change in Functional connectivity | Baseline, 2 months | Change in Functional connectivity of the brain networks as assessed by measure of connectivity in multimodal MRI. | ClinicalTrials.gov |
| Secondary | Change in peripheral blood cytokines | Baseline, 1 months, 2 months | Peripheral blood sample will be collected and the concentration of IL-6, TNF-α, and CRP will be assessed. | ClinicalTrials.gov |
| Secondary | Change in feces bacterial flora | Baseline, 1 months, 2 months | The objective of investigator is to characterize gut microbiome in patients with TRD. To explore the specific diversity of gut microbiome. The stool samples were collected in the collection kits at the baseline, and were frozen at -80 °C. After the process of DNA Purification, 16S rRNA Gene Amplification and Illumina MiSeq sequencing, the study finally find the abundance and diversity of microbiota. | ClinicalTrials.gov |
| Secondary | Change in Congruent STROOP Time to Complete (Executive Function) | Baseline, 1 months, 2 months | Stroop Colour Naming Test (STROOP) is a cognitive test designed to assess the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises two sheets with 50 words on each, and each word is the name of a colour. On the first sheet, the Congruent STROOP Sheet, the word and ink colour match; on the Incongruent STROOP Sheet, the word and ink colour do not match. For each sheet, the patient has 4 minutes to name the ink colour of each word. When the patient finishes the sheet, or once 4 minutes is up, the clinician notes the time taken and counts the number of correct and incorrect responses. The scale ranges from 0-100, the higher score the greater the cognitive flexibility. | ClinicalTrials.gov |
| Secondary | Change in DSST (Number of Correct Symbols) | Baseline, 1 months, 2 months | Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning)." as a description of DSST. | ClinicalTrials.gov |
| Secondary | Improvement on Snaith-Hamilton Pleasure Scale (SHAPS) | Baseline, 1 months, 2 months | The Snaith-Hamilton Pleasure Scale (SHAPS) assesses the anhedonia symptoms of MDD patients, with higher score indicating more severe anhedonia. Evaluating the patient's pleasure experience and choosing the degree of agreement with the happy response in some pleasant situations, and each item was rated on a 4-point scale."1 = Strongly agree, 2 = agree, 3 = disagree and 4 = strongly disagree" This scale evaluates the status of patients in the recent period of time, The total score of the scale is the sum of the scores of 14 items, with a total score of 14-56. The higher the total score, the more serious the anhedonia. | ClinicalTrials.gov |
| Secondary | Young Manic Rating Scale (YMSR) | Baseline, 1 months, 2 months | The YMSR assesses the manic symptoms of the subjects. | ClinicalTrials.gov |
| Secondary | Life Event Scale (LES) | Baseline, 1 months, 2 months | The LES assesses the effects of some life events on the subjects. | ClinicalTrials.gov |
| Secondary | Beck Scale for Suicide Ideation（BSI） | Baseline, 1 months, 2 months | The BSI assesses the Suicide Ideation of the subjects, including two time points, the latest week and when the subjects were the most depressive. | ClinicalTrials.gov |
| Secondary | Hopkins Vocabulary Learning Test-Revised (HVLT-R) | Baseline, 1 months, 2 months | The HVLT-R assesses the memory and the cognition of the subjects. | ClinicalTrials.gov |
| Secondary | Sydney Melancholia Prototype Index (SMPI) | Baseline, 1 months, 2 months | The SMPI aims to identify the melancholic and non-melancholic depression. | ClinicalTrials.gov |
| Secondary | Generalized Anxiety Disoder-7 (GAD-7) | Baseline, 1 months, 2 months | The GAD-7 aims to assesses the severity of anxious symtoms. | ClinicalTrials.gov |
| Secondary | Self-reported Quick Inventory of Depressive Symptomatology (QIDS-SR) Scale | Baseline, 1 months, 2 months | The QIDS-SR assesses the depressive symtoms in latest week of subjects quickly. | ClinicalTrials.gov |
| Secondary | Dimensional Anhedonia Rating Scale (DARS) | Baseline, 1 months, 2 months | The DARS assesses different dimensions in Anhedonia of the subjects. | ClinicalTrials.gov |
| Secondary | Child Trauma Scale (CTQ) | Baseline, 1 months, 2 months | The CTQ assesses child trauma happen to the subjects. | ClinicalTrials.gov |
| Secondary | Sheehan Disability Scale (SDS) | Baseline, 1 months, 2 months | The SDS assesses the impairment in the occupational, familial and social ability of the subjects. | ClinicalTrials.gov |
| Secondary | Pittsburgh Sleep Quality Index (PSQI) | Baseline, 1 months, 2 months | The PSQI assesses the sleep quality of the subjects. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 37304432 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)